Omnicom Ocasio
Active material: Tamsulozin
When ATH: G04CA02
CCF: Preparation, used in violation of urination, associated with benign prostatic hyperplasia. Alpha1-adrenoblokator
Codes ICD-10 (testimony): N40
When CSF: 28.01.02.01
Manufacturer: ASTELLAS PHARMA EUROPE B.V. (Netherlands)
Pharmaceutical form, composition and packaging
Controlled release tablets, coated from yellow to brownish-yellow, round, lenticular, embossed on one side “04”.
| 1 tab. | |
| tamsulosin hydrochloride | 400 g |
Excipients: macrogol 8000, macrogol 7 000 000, magnesium stearate.
The composition of the shell: Opadry Yellow 03F22733 (gipromelloza, macrogol 8000, dye iron oxide yellow), Purified water.
10 PC. – blisters (1) – packs cardboard.
10 PC. – blisters (3) – packs cardboard.
Pharmacological action
Alpha1-adrenoblokator. It is a specific competitive blocker of postsynaptic α1-adrenoreceptorov, особенно a1A и a1D podtypov, located in the smooth muscle of the prostate, bladder neck, prostatic urethra and detrusor. It reduces the tone of smooth muscles of the prostate and urethra, improving the flow of urine, reduces the phenomenon of instability of the bladder. This reduces the symptoms obstruction (emptying) and irritation (filling), associated with benign prostatic hyperplasia. Describe the impact on the symptoms of obstruction and irritation persists with prolonged use.
Антагонисты a1-adrenergic receptors can reduce blood pressure by reducing systemic vascular resistance. In applying the drug Omnic® Okas in a daily dose 400 micrograms of clinically significant reductions in blood pressure were noted.
Pharmacokinetics
Absorption
Omnic® Okas is a tablet with controlled release through the gel matrix using nonionic type, which ensures a long and slow release of tamsulosin, and provides sufficient exposure to weak vibrations over the 24 no.
Tamsulosin in the form of Omnic® Okas absorbed from the gastrointestinal. Absorption sostavlyaet 57%. On the absorption of tamsulosin in the form of Omnic® Okas meal no effect. Tamsulosin is characterized by linear pharmacokinetics. After a single oral dose of the drug on an empty stomach 400 µg Cmax tamsulosin in plasma is achieved at a mean 6 no. In the equilibrium state, which is achieved by 4 Day reception, Cmax tamsulosin in plasma achieved through 4-6 h as in the fasting state, and postprandial. There are significant differences in the values of individual plasma concentrations after a single dose and repeated use.
Distribution
Plasma protein binding is about 99%, Vd little – about 0.2 l / kg.
Metabolism
Tamsulosin is slowly metabolized by the liver to produce less active metabolites. Most of tamsulosin in plasma is presented in an unmodified form. According to the experimental studies of the ability to induce the activity of microsomal liver enzymes have virtually no tamsulosin.
Deduction
Tamsulosin and its metabolites are excreted primarily in the urine, with about 4-6% the drug is excreted unchanged in.
Upon receipt of Omnicom® Okas a dose 400 micrograms once and at steady state T1/2 is 19 and h 15 h, respectively.
Testimony
- Benign prostatic hyperplasia (treatment of dysuria).
Dosage regimen
Assign inside of 400 g (1 tab.) 1 time / day regardless of the meal. The tablet should be taken as a whole, without chewing, to avoid interfering with a prolonged release of the active substance.
Side effect
Criteria for assessing the incidence of side effects: often – >1%, <10%; sometimes – >0.1%, <1%; rarely – >0.01%, <0.1%; rarely – <0.01%.
Cardio-vascular system: sometimes – palpitations, postural hypotension.
From the digestive system: sometimes – constipation, diarrhea, nausea, vomiting.
CNS: 1.3% – dizziness; sometimes – headache; rarely – fainting.
On the part of the reproductive system: sometimes – abnormal ejaculation; rarely – priapism.
The respiratory system: sometimes – rhinitis.
Allergic reactions: sometimes – skin rash, itch, hives; rarely – angioedema.
Other: sometimes – asthenia.
Contraindications
- Orthostatic hypotension;
- Severe hepatic impairment;
- Hypersensitivity to tamsulosin or any other component of the drug.
FROM caution use in patients with chronic renal failure (CC less than 10 ml / min).
Cautions
In applying the drug Omnic® Okas (as well as other alpha1-adrenoblokatorov) In some cases there may be a decrease in blood pressure, which in rare cases leads to fainting. At the first signs of orthostatic hypotension (dizziness, weakness) the patient must sit or lie down and to remain in that position until, until the symptoms of this condition will not go away.
When surgery for cataracts in patients receiving the drug may develop the syndrome intraoperative instability iris (Syndrome narrow pupil), it is necessary to consider surgery for preoperative preparation of the patient during the operation.
Before starting therapy with Omnic® Okas patient must be examined in order, to exclude the presence of other diseases, which can cause similar symptoms, as well as benign prostatic hyperplasia. Before you start treatment and regularly during treatment is necessary to carry out a digital rectal examination and, if required, determination of prostate specific antigen (PSA).
In renal insufficiency, no dosage adjustment is required.
Effects on ability to drive vehicles and management mechanisms
During treatment, patients should be careful when driving and other activities, require high concentration and speed of psychomotor reactions.
Overdose
Symptoms: severe hypotension.
Treatment: to prevent further absorption of the drug it is advisable to carry out gastric lavage, an appointment of activated charcoal and an osmotic laxative, eg, Sodium sulfate; Blood pressure and heart rate can recover, if the patient placed in a horizontal position. In the absence of the effect can be applied means, OCK and uvelichivayushtie, if necessary, vasoconstrictors. It should monitor kidney function. Unlikely, that dialysis would be effective, tk. tamsulosin extensively bound to plasma proteins.
Drug Interactions
In the appointment of tamsulosin concurrently with atenolol, Enalapril, nifedipine or theophylline drug interactions were found.
In an application with cimetidine was a slight increase in the concentration of tamsulosin in plasma; furosemide – reduction of the concentration, however, this requires changing the dose Omnic® Okas, because its concentration remains within the normal range.
Diazepam, propranolol, trixlormetiazid, xlormadinon, Amitriptyline, diclofenac, glibenclamide, simvastatin and warfarin change tamsulosin free fraction in human plasma in vitro. In turn serves as tamsulosin free fractions of diazepam, propranolol, trichlormethiazide and chlormadinone.
In in vitro studies found no interaction at the level of hepatic metbolizma with amitriptyline, salbutamol, glibenclamide and finasteride. Diclofenac and Warfarin may increase the elimination rate of tamsulosin.
Simultaneous administration of other α antagonists1-adrenergic receptors can lead to a hypotensive effect.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children at or above 25 ° C. Shelf life – 3 year.
